User Testing – Center Labmgmu

+7 (495) 150 41 90

User Testing

We conduct prompt and high-quality user testing of instructions for medical use and package inserts.

When IMU/PI user testing is needed?

According to Resolution of EEC No88 On Approval of Requirements to the Instructions for Medical Use of Medicinal Drugs and Summary of Product Characteristics:

New clinical guidelines, new patient populations

If a medicinal product (MP) contains new chemical compounds

If major changes concerning the product safety were introduced in the package insert (PI) tested earlier

Если ЛП выпускается в принципиально новых лекарственных формах или изменились условия отпуска ЛП

LABMGMU has expertise in the field of user testing

A detailed testing report for your MP will support successful marketing authorization of the MP by the authorized bodies.

LABMGMU strictly follows the EEC Resolution No 78 and No 88 requirements

To user testing, strictly abiding by protocols and requirements of the authorized bodies.

Why ordering a user testing at LABMGMU –ensures high quality and predictable result?

We customize the testing process with account of key safety requirements of your medicinal drug.

We enroll respondents by age, sex, specifically for your project and according to the requirements of EEC No 88.

Transparent testing process: testing schedule, questions and conditions of testing are available to you prior to its start.

Intermediate reports. You receive reports after every testing stage and can made amendments based on the pilot or first stage testing outcomes.

At the end of the 3 stages of testing you receive a final user testing report including individual demographic data of participants, and a summary report.

Entrusting your project to LABMGMU
you get:

1. Development of IMU/PI test questions by experienced professionals of our science department;
2. Development of a user testing questionnaire;
3. Prompt participant enrollment for testing;
4. Fast completion of user testing;
5. Intermediate and final user testing reports.